FDA 510(k) clearance · back to tracker

ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

American Medical Systems, Inc. cleared K090713 on 2009-04-02, decision: substantially equivalent

K-number

K090713

Sponsor

American Medical Systems, Inc.

Device

ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP

Class

Class III

Decision

Substantially Equivalent

Decision date

2009-04-02

Product code

OTP

Advisory committee

Obstetrics/Gynecology

Medical specialty

Obstetrics/Gynecology

Regulation number

884.5980

Official FDA record

Open K090713on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.